Exhibits

The following Exhibits were presented to the FDA and are presented here as evidence that reusing Blades for LASIK surgery is within the jurisdiction of the FDA and the Federal government to investigate.

If the FDA has No jurisdiction to regulate an already approved medical device that is known to be used unsafely and contrary to the public health, then what's the point of approving these devices as safe in the first place? What do they actually review during the medical device reviews?

How many people would resist saving over $1million by taking some extra risk (for someone else, not themself) if no one would do anything about it?

These medical devices are provided Only under "A license for single-use only procedure". . . "with the purchase of each single-use". . ."disposable blade". "Caution: Federal Law (U.S.A.) restricts this device to sale, by or on the order of, a physician".Click here for Exhibit A

The FDA has a "CHECKLIST OF COMPLIANCE WITH ESSENTIAL REQUIREMENTS OF MEDICAL DEVICES DIRECTIVE, #2.Essential Requirements". Isn't the Doctor also required to follow the procedures for use of the device to also eliminate and reduce risks as far as possible (including properly using the blades ONLY once and sterilizing them and the cannulas)?These risks include permanent patient injury).Note particularly item 4 where it indicates that the device MUST NOT be adversely affected such that it jeopardizes patient safety "when the device is subjected to the stresses which can occur during normal conditions of use", Click here for Exhibit B

Is even the recommended sterilization sufficient to protect people from infectious diseases including HIV (Aids) and CJD (Mad Cow)? The manufacturers recommend using EtO sterilization, but that uses low heat instead of autoclaving.

Does the FDA do anything if the users of these FDA approved Class I medical devices do not follow the Operator Manual procedures (see Exhibit D, including sterilization and cleaning off of debris)?

"34. WarningThe Hansatome microkeratome must be cleaned, disinfected and/or sterilized according to the instructions provided in this manual.Failure to properly clean, disinfect, and sterilize equipment could result in possible serious permanent patient injury."

"36. WarningAny delay in cleaning can allow residual debris from the procedure to adhere to the Hansatome microkeratome.Such debris could clog the Hansatome microkeratome and during sterilization, could harden and become permanently lodged.Debris allowed to build up on the Hansatome microkeratome components could affect the performance of the system resulting in system malfunction and possible permenant patient injury."

According to the FDA, this license is required under Title 21 of Federal law, but NO MATTER HOW MUCH evidence is presented to the FDA of a civil or criminal violation of Title 21 or any other Federal law regarding the use of these devices, and No matter how much evidence is presented that the violation did NOT involve the practice of medicine (see http://www.lasikliberty.com/index.php?option=com_content&task=view&id=28&Itemid=43), the FDA specifies that only the local and State authorities have jurisdiction over the users of these devices.

I read Title 21 and I do Not see an exemption or exception for a medical Doctor who violates Federal law. The FDA implies there's an "off-label" use exemption for any medical Doctor, but that Only applies if there's a patient benefit. There's no patient benefit for reusing blades and Not sterlizing them properly. Why does the FDA approve the devices in the first place if the Only users are Medical Doctors, if the Medical Doctors can use them in a way that is directly opposed to the patients' best interests, and the users do Not have to use them as approved or safely?

"Ralph A. Rosenthal, M.D., director of FDA's division of ophthalmic devices, says, 'The agency has ruled that individual physicians can perform LASIK under the general 'practice of medicine,' if it's in the patient's best interest."

If the FDA does Not have jurisdiction over the users of the devices, then why do they state that their labeling and Federal law does extend to those same users? If that was true, then the only purpose of the FDA approving the device in the first place that I can think of would be to help those users of the devices advertise and reassure victims who they know they will injure by Not using the medical device safely and effectively.

Does the FDA and the Federal Government actually seek to protect the public health or are their stated mission and goals outside the FDA's jurisdiction?

Is the FDA saying that what "safe" and "effective" means is that it is possible to use the medical device safely and effectively, but users are free to use it however they see fit as a "off-label" use? Does the FDA care whether or Not the device is actually used safely or effectively? What authority and resources do local and state authorities have to make sure that FDA approved medical devices are used safely and effectively?

Does the FDA selectively prosecute some practictioners and users of their approved devices and Not others? Wouldn't it be great to advertise an FDA approved medical device as safe and effective and then to save millions of $s by reusing the components contrary to what the FDA says is safe and effective, and there is No Federal jurisdiction to even investigate? What government agency aside from the FDA even understands the Federal laws, labeling, clinical trials, and other information well enough to know how the devices are supposed to be used safely? The medical devices and documentation is Only provided to the users of the device. Not every patient will know they were injured or even assaulted by the user of the device because the FDA will Not even investigate how they are using the device.

The FDA even implies the risks are lower the more surgeries the Doctor does regardless of whether they follow the Operators manual for the device, replace the blades, do any sterlization, cut costs wherever possible, provide patients true informed consent (including providing the patient handbook), etc.

"Under the care of an experienced doctor, carefully screened candidates with reasonable expectations and a clear understanding of the risks and alternatives are likely to be happy with the results of their refractive procedure.

Finding the Right Doctor
If you are considering refractive surgery, make sure you:

Compare. The levels of risk and benefit vary slightly not only from procedure to procedure, but from device to device depending on the manufacturer, and from surgeon to surgeon depending on their level of experience with a particular procedure.

Read. It is important for you to read the patient handbook provided to your doctor by the manufacturer of the device used to perform the refractive procedure. Your doctor should provide you with this handbook and be willing to discuss his/her outcomes (successes as well as complications) compared to the results of studies outlined in the handbook. "

Is the FDA focused on protecting the public health or meeting their minimun appropriation level of $220million for FY 2006? The FDA receives over $40million in addition user fees alone and will Not even investigate users who are known to use their approved medical devices in an unsafe manner by Not following the Operators manuals or even properly sterilizing reused single-use, disposable devices.

"FDA is requesting a $5,996,000 increase for medical device review, along with $40,300,000 in additional user fees for the Devices and Biologics Program. This will allow the Agency to meet the minimum statutory appropriation level of $220,823,000 for FY 2006. Without this increase, our ability to continue to collect user fees would be jeopardized.

Medical Device Program: +$5,996,000

To strengthen FDA's medical device review process, the Medical Device User Fee and Modernization Act (MDUFMA) was authorized in FY 2002. MDUFMA is a multi-year effort to improve the quality and timeliness of the medical device review process, by authorizing the collection of user fees and creating an aggressive set of performance goals. This legislation only allows the Agency to collect user fees if a number of "triggers" are met, including achieving a certain level of budget authority for the Medical Devices and Radiological Health program. The ability to collect this user fee is critical to strengthen the medical device review process and to meet the medical device review goals by 2007."